Drugs
Genomics
- Genomics Overview
- What’s New and Upcoming Events
- Regulatory and Scientific Information
- Guidances, Concept Papers and MaPPs
- Table of Valid Genomic Biomarkers in the Context of Approved Drug Label
- Genomic Data Submission
- Decision Tree for Genomic Data Submission
- Voluntary Exploratory Data Submission (VXDS) [formerly Voluntary Genomic Data Submission (VGDS)]
- Quick Reference Guide
- Interdisciplinary Pharmacogenomics Review Group (IPRG)
- Frequently Asked Questions
- Pharmacogenomics Education and Outreach Initiatives
- Drug Development and Drug Interactions
- Publications by FDA Staff
- Presentations
- Related Links
- Contact Information
Genomics Overview
Pharmacogenomics allows us to identify sources of an individual’s profile of drug response and predict the best possible treatment option for this individual. The use of genomic information, accelerated by the sequencing of the human genome and the advent of new tools and technologies, has opened new possibilities in drug discovery and development. Consequently, regulatory science and regulations are set in place appropriately, as new scientific evidence is forthcoming.
FDA recognizes the importance of pharmacogenomics and encourages its use in drug development. This is reflected in the FDA white paper “Stagnation or Innovation? – Challenge and Opportunity on the Critical Path to New Medical Products,” which identifies pharmacogenomics as a key opportunity for the Critical Path.
Several guidance documents are being developed that provide information on the Agency’s current thinking and the use of pharmacogenomics for regulatory decision making. These guidances are complemented by FDA procedural documents (e.g., MaPPs and SOPPs), which go into more detail for specific regulatory issues.
In addition, the FDA has created a training program in genomics for all stakeholders and also engages in several applied research projects to support and promote the translation of pharmacogenomics from basic research, drug discovery and development into clinical practice, focused on ensuring its proper employment to protect public health.
For more information on genomics, please see the FDA Drug Safety Newsletter focusing on clinical implication of safety Volume 1, Number 2, Winter 2008.
Issam Zineh, PharmD, MPH
Associate Director of Genomics
Office of Clinical Pharmacology
- email: fdagenomics@fda.hhs.gov
- telephone: (301) 796-4756
- facsimile: (301) 847-8720